Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined. Methods: This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months. Conclusion This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.

PURPOSE: To determine whether serum insulin and glucagon levels of umbilical cord blood correlate with subsequent postnatal hypoglycemia in appropriate for gestational age (AGA) - preterm infants at different gestational ages (GAs). METHODS: The serum insulin and glucagon levels of umbilical cord blood were measured using magnetic bead based multiplex immunoassay in 69 AGA - premature infants, stratified according to GA: GA 23-30 weeks, early preterm (EP, n=31); GA 31-34 weeks, late preterm (LP, n=38). Postnatal hypoglycemia was defined as a capillary glucose level <40 mg/dL within the first 60 minutes of life, regardless of GA. RESULTS: The capillary glucose concentration in EP infants (65.5±21.2 mg/dL) was significantly higher than that of LP infants (55.9±17.3 mg/dL) (P=0.043). The serum glucagon level in EP infants (44.3±28.7 pg/mL) was significantly higher than that in LP infants (28.1±13.6 pg/mL) (P=0.006). There was not a significant difference in serum insulin level between EP and LP infants (372.7±254.2 pg/mL vs. 372.4±209.1 pg/mL, P=0.996). There was a significant difference in the serum glucagon level between infants with and without hypoglycemia (27.7±8.9 mg/dL vs. 36.8±24.6 mg/dL, P=0.036), but not in the serum insulin level (451.9±256.9 pg/mL vs. 357.4±222.2 pg/mL, P=0.211). Postnatal glucose concentration within the first 60 minutes of life had a significant positive correlation with serum glucagon levels (r=0.256, P=0.034), but not with serum insulin levels (r=-0.020, P=0.867). CONCLUSION: Lower glucagon levels of cord blood were seen in premature infants with higher GA, which might contribute to the occurrence of postnatal hypoglycemia.
Capillaries ; Fetal Blood* ; Gestational Age* ; Glucagon* ; Glucose ; Humans ; Hypoglycemia* ; Immunoassay ; Infant ; Infant, Newborn ; Infant, Premature* ; Insulin* ; Umbilical Cord*

PURPOSE: To determine whether serum insulin and glucagon levels of umbilical cord blood correlate with subsequent postnatal hypoglycemia in appropriate for gestational age (AGA) - preterm infants at different gestational ages (GAs). METHODS: The serum insulin and glucagon levels of umbilical cord blood were measured using magnetic bead based multiplex immunoassay in 69 AGA - premature infants, stratified according to GA: GA 23-30 weeks, early preterm (EP, n=31); GA 31-34 weeks, late preterm (LP, n=38). Postnatal hypoglycemia was defined as a capillary glucose level <40 mg/dL within the first 60 minutes of life, regardless of GA. RESULTS: The capillary glucose concentration in EP infants (65.5±21.2 mg/dL) was significantly higher than that of LP infants (55.9±17.3 mg/dL) (P=0.043). The serum glucagon level in EP infants (44.3±28.7 pg/mL) was significantly higher than that in LP infants (28.1±13.6 pg/mL) (P=0.006). There was not a significant difference in serum insulin level between EP and LP infants (372.7±254.2 pg/mL vs. 372.4±209.1 pg/mL, P=0.996). There was a significant difference in the serum glucagon level between infants with and without hypoglycemia (27.7±8.9 mg/dL vs. 36.8±24.6 mg/dL, P=0.036), but not in the serum insulin level (451.9±256.9 pg/mL vs. 357.4±222.2 pg/mL, P=0.211). Postnatal glucose concentration within the first 60 minutes of life had a significant positive correlation with serum glucagon levels (r=0.256, P=0.034), but not with serum insulin levels (r=-0.020, P=0.867). CONCLUSION: Lower glucagon levels of cord blood were seen in premature infants with higher GA, which might contribute to the occurrence of postnatal hypoglycemia.
Capillaries ; Fetal Blood* ; Gestational Age* ; Glucagon* ; Glucose ; Humans ; Hypoglycemia* ; Immunoassay ; Infant ; Infant, Newborn ; Infant, Premature* ; Insulin* ; Umbilical Cord*

PURPOSE: To investigate the diameter, the infusion and aspiration rate of 20-, 23- and 25-gauge vitreous cutters, and compare the theoretical and practical intraocular pressure (IOP) change according to the height of the bottle. METHODS: A vitreous cutter was disassembled to measure the actual external and internal diameter. The infusion rate was measured at the height of 40, 60, 80, 100 and 120 cm and the suction rate was measured at a pressure of 100, 200, 300, 400 and 500 mm Hg for each gauge. IOP during the operation was calculated according to the bottle height and the actual IOP was measured using a mercury sphygmomanometer. RESULTS: The external diameter of the 20-, 23- and 25-gauge was 900, 596, and 500 mm, respectively, and the internal diameter was 670, 450, and 380 mm, respectively. The infusion rate increased in direct proportion to the bottle height. The aspiration rate increased as the pressure increased. However, the increment of the infusion and aspiration rate in the 20-gauge vitreous cutter was the highest and decreased in the 23- and 25-gauge, in that order. IOP was calculated as 29, 44, 59 and 74 mm Hg when the bottle height was at 40, 60, 80 and 100 cm, respectively, and was measured 34, 50, 62 and 74 mm Hg, respectively. CONCLUSIONS: The infusion and aspiration rates per outer diameter in the 23- and 25-gauge vitreous cutters and infusions using cannula were lower than in the 20-gauge vitreous cutter. The difference of the infusion and aspiration rates per diameter between the 23- and 25-gauge vitreous cutters and infusions was not significant.
Catheters ; Intraocular Pressure ; Suction ; Surgical Instruments

PURPOSE: To determine the clinical outcome of intravitreal bevacizumab injection in patients with ischemic central retinal vein obstruction (CRVO). METHODS: The present study was conducted retrospectively on 56 eyes of 56 patients who were diagnosed with CRVO and classified according to ischemic and non-ischemic type and underwent an intravitreal bevacizumab injection. The present study measured changes in visual acuity and central macular thickness, neovascularization in the anterior segment, development of neovascular glaucoma and other clinical complications. RESULTS: The average number of bevacizumab injections in both groups was 2.07 and 1.62 in the ischemic type. No patients developed neovascular glaucoma in the non-ischemic type group, 14 of 26 eyes in the ischemic type group developed neovascular glaucoma and the mean time to diagnosis was 28.75 weeks. log MAR visual acuity of the ischemic type group prior to injection was 1.56 +/- 0.65 on average which improved to 1.44 +/- 0.97 (p = 0.45). CONCLUSIONS: Intravitreal bevacizumab injection improves the condition of cystic macular edema clinically, but does not affect the development of neovascular glaucoma and improvement of visual acuity in ischemic type CRVO.
Antibodies, Monoclonal, Humanized ; Eye ; Glaucoma, Neovascular ; Humans ; Macular Edema ; Retinal Vein ; Retrospective Studies ; Visual Acuity ; Bevacizumab

PURPOSE: Although infants with bronchopulmonary dysplasia (BPD) are at risk of developing secondary pulmonary hypertension (PH), which is associated with significant morbidity and mortality, little has been reported about the incidence, clinical course and prognosis of PH secondary to BPD in premature infants. This study was done to investigate the incidence, risk factors, clinical course, and the ultimate prognosis of PH developed secondary to BPD in very low birth weight infants (<1,500 g). METHODS: Medical records of very low birth weight infant (VLBWI) admitted to Samsung Medical Center NICU from January 2000 to July 2007 were reviewed retrospectively. BPD was defined by Jobe's classification. The diagnosis of pulmonary hypertension was established as velocity of tricuspid valve regurgitation (TR) > or =3 m/s and a flattening of the intraventricular septum by conducting Doppler echocardiography. RESULTS: The incidence of pulmonary hypertension was 6% in VLBWI with BPD and it developed in moderate to severe BPD. The diagnosis of pulmonary hypertension was made on postnatal 133 days (range 40-224 days) and the risk factors related to developing pulmonary hypertension were severe BPD, small for gestational age and outborn infants. The mortality rate was 57% and especially higher in severe BPD (70%). The time to recovery spent 3 months (range 1-10 months) in survived patients. CONCLUSION: Based on the results of this research, pulmonary hypertension secondary to BPD in VLBWI related to severity of BPD and had a poor prognosis. We expect that regular long-term echocardiography may be helpful in treating reversible in VLBWI with moderate to severe BPD.
Bronchopulmonary Dysplasia ; Echocardiography ; Gestational Age ; Humans ; Hydrogen-Ion Concentration ; Hypertension, Pulmonary ; Incidence ; Infant ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Medical Records ; Prognosis ; Retrospective Studies ; Risk Factors ; Tricuspid Valve Insufficiency